Posted by Michael Wonder on 03 Feb 2019
CHMP recommends EU approval of Roche’s Hemlibra for people with severe haemophilia A without factor VIII inhibitors
1 February 2019 - First medicine to significantly reduce treated bleeds compared to prior factor VIII prophylaxis in a prospective intra-patient comparison.
Roche today announced that the EU Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Hemlibra (emicizumab) for routine prophylaxis of bleeding episodes in adults and children with severe haemophilia A (congenital factor VIII deficiency, FVIII <1%) without factor VIII inhibitors. The CHMP has also recommended that Hemlibra can be used at multiple dosing options (once weekly, every two weeks, or every four weeks) for all indicated people with haemophilia A, including those with factor VIII inhibitors.
The positive CHMP opinion is based on results from the pivotal HAVEN 3 and HAVEN 4 studies.
